Imatinib in Combination With Dacarbazine and Capecitabine in Medullary Thyroid Carcinoma
To determine the maximum tolerated doses (MTD) for the combination of imatinib mesylate, capecitabine, and dacarbazine in patients with solid tumors.
To determine the overall tumor response rate to imatinib mesylate in combination with capecitabine and dacarbazine as first line and second line therapy in advanced metastatic medullary thyroid carcinoma.
To determine the tolerability (toxicity) of this regimen.
To determine the median overall survival (OS) and time to progression (TTP) for patients treated with this combination.
Drug: Capecitabine (Xeloda)
Drug: DTIC-Dome (Dacarbazine)
Drug: Gleevec (Imatinib Mesylate)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study to Evaluate the Efficacy and Toxicity of Imatinib Mesylate in Combination With Dacarbazine and Capecitabine in Medullary Thyroid Carcinoma|
- Maximum tolerated doses (MTD) for the combination of imatinib mesylate, capecitabine, and dacarbazine [ Time Frame: 21 day cycle ] [ Designated as safety issue: Yes ]The MTD is defined as the dose level below that producing dose limiting toxicity (DLT; i.e. any Grade 4 hematologic toxicity and /or non hematological toxicity >/= Grade 3 in 2/6 participants).
- Objective Response Rate [ Time Frame: Minimally 9 weeks (overall study period 5 years) ] [ Designated as safety issue: No ]Objective response rate is defined to be the proportion of participants achieving Complete Response (CR) or Partial Response (PR). Response to treatment will be measured using the RECIST criteria with radiological evaluation every 9 weeks.
|Study Start Date:||December 2004|
|Study Completion Date:||August 2013|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
Experimental: Capecitabine + Dacarbazine + Imatinib
Capecitabine starting Dose 500 mg/m^2 twice a day Days 1-14 of 21 Day Cycle. Dacarbazine starting Dose 250 mg/m^2 a day on Days 1-3 of 21 Day Cycle. Imatinib starting Dose 400 mg a day on Days 1-21 of 21 Day Cycle.
Drug: Capecitabine (Xeloda)
Starting Dose 500 mg/m^2 twice a day Days 1-14 of 21 Day Cycle.Drug: DTIC-Dome (Dacarbazine)
Starting Dose 250 mg/m^2 a day on Days 1-3 of 21 Day Cycle.Drug: Gleevec (Imatinib Mesylate)
Starting Dose 400 mg a day on Days 1-21 of 21 Day Cycle.
Other Name: Imatinib
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00354523
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||James Yao, MD||M.D. Anderson Cancer Center|